Table 4.
Safety profile during week 16 (placebo-controlled period) and the entire safety reporting period
| Variable | Through week 16 (placebo-controlled period)a | Entire safety-data period | ||||
|---|---|---|---|---|---|---|
| Secukinumab IV-300 mg (N = 76) | Secukinumab IV-150 mg (N = 74) | Placebo (N = 75) | Any secukinumab 300 mg (N = 113) | Any secukinumab 150 mg (N = 110) | Any secukinumab (N = 223) | |
| Exposure to study treatment, days, mean ± SD | 112.9 ± 14.2 | 117.4 ± 13.1 | 112.2 ± 19.4 | 410.7 ± 108.9 | 425.9 ± 92.4 | 418.2 ± 101.1 |
| Number of patients (%) | Number of patients (incidence rate per 100 patient years) | |||||
| Any AE | 34 (44.7) | 34 (45.9) | 33 (44.0) | 83 (152.7) | 90 (179.2) | 173 (165.4) |
| Serious AE | 1 (1.3) | 0 (0.0) | 1 (1.3) | 6 (4.8) | 6 (4.8) | 12 (4.8) |
| Discontinued due to AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (3.5) | 4 (3.6) | 8 (3.6) |
| Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Common AEsa | ||||||
| Nasopharyngitis | 3 (3.9) | 6 (8.1) | 2 (2.7) | 16 (13.7) | 22 (19.6) | 38 (16.6) |
| Diarrhea | 3 (3.9) | 5 (6.8) | 0 (0.0) | 8 (6.6) | 9 (7.5) | 17 (7.0) |
| Headache | 3 (3.9) | 5 (6.8) | 5 (6.7) | 11 (9.1) | 12 (10.1) | 23 (9.6) |
| Cough | 3 (3.9) | 3 (4.1) | 1 (1.3) | 5 (4.1) | 3 (2.4) | 8 (3.2) |
| Pharyngitis | 3 (3.9) | 1 (1.4) | 1 (1.3) | 4 (3.2) | 3 (2.4) | 7 (2.8) |
| Ear infection | 3 (3.9) | 0 (0.0) | 0 (0.0) | 3 (2.4) | 0 | 3 (1.2) |
| Urinary tract infection | 3 (3.9) | 0 (0.0) | 3 (4.0) | 6 (4.9) | 3 (2.4) | 9 (3..6) |
| AEs of special interest | ||||||
| Candida infection | 1 (1.4) | 1 (1.3) | 0 (0.0) | 2 (1.8) | 2 (1.8) | 4 (1.8) |
| Malignant tumor | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
| Neutropenia | ||||||
| Grade 3 | 0 (0.0) | 1 (1.4) | 0 (0.0) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
| Grade 4 | 0 (0.0) | 2 (2.7) | 0 (0.0) | 0 (0.0) | 2 (1.8) | 2 (0.9) |
The entire safety reporting period includes all safety data up to the date cutoff of the last patient’s week 52 clinic visit. One patient was excluded from placebo group as no treatment was given after randomization. In the analysis of the entire study period, the secukinumab groups include any patients who received the stated dose of secukinumab, including those who were randomly assigned to the placebo group at baseline and who underwent a second randomization to active treatment at week 16
N number of patients, AE adverse event, SD standard deviation
aAEs with frequency ≥3% in either of the two secukinumab groups during the 16-week placebo-controlled period